Pre-loaded delivery device with tri-fold proximal prosthesis attachment

ABSTRACT

A pre-loaded prosthesis delivery device is described. In one example, the prosthesis delivery device is pre-loaded with a single wire that allows the device to be tracked into place within a vessel and also facilitates cannulation of a branch vessel. The delivery device further comprises a prosthesis that is releasably coupled to a delivery catheter by using two attachment wires to secure the proximal end of the prosthesis to the delivery device in a tri-fold configuration.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional application No. 62/128,705, filed on Mar. 5, 2015, and also claims priority to U.S. Provisional application No. 62/148,006 filed on Apr. 15, 2015, which applications are incorporated by reference herein in their entireties.

TECHNICAL FIELD

This disclosure relates to introduction systems for the delivery and deployment of implantable medical prostheses. In particular, this invention relates to a stent graft delivery device or introducer pre-loaded with a guide wire that facilitates both device tracking and cannulation, with a tri-fold attachment mechanism to couple the prosthesis to the delivery device.

BACKGROUND

The introduction and deployment of a medical device such as a stent or stent graft into a patient is a well-known procedure. The introducer may include an external manipulation section or handle, an inner catheter that may accommodate a guide wire, a medical device carried by the inner catheter, a nose cone dilator at the proximal end of the inner catheter and a retractable outer sheath. The medical device is generally coupled to the proximal end of the introducer. During deployment, the medical device is released from the introducer, first by retraction of the sheath, and/or the operation of other release mechanisms to facilitate expansion of the device in the body vessel.

Descending thoracic aortic aneurysms and dissections are often treated by placing a stent graft in the affected region of the vessel. In some procedures, the affected region (i.e., the location of an aneurysm or dissection) necessitates creating a seal with the stent graft at the location of a branch vessel extending from the main vessel, such as the left subclavian artery extending from the aortic arch, for example. In such cases, a fenestrated and/or branched graft may be used to maintain patency of both the main vessel and the branch vessel.

Accordingly, it may be desirable and advantageous to provide a stent graft delivery device or introducer that is pre-loaded with a single guide wire which can facilitate the delivery of the stent graft to the desired location within a vessel as well as the cannulation of one or more branch vessels. It may also be desirable to releasably couple the stent graft to the delivery device with an attachment mechanism including a proximal tri-fold configuration.

SUMMARY

In one example, a prosthesis delivery device is disclosed. The delivery device comprises a delivery catheter having a proximal end and a tubular prosthesis releasably coupled to the proximal end of the delivery catheter. The prosthesis has a proximal end, a distal end, a lumen extending between the proximal end and distal end, a sidewall of graft material, an inner graft surface, an outer graft surface, and a fenestration formed in the sidewall of the prosthesis. The delivery catheter extends proximally through at least a portion of the prosthesis lumen and through the fenestration to a location external of the prosthesis and adjacent a first point on the outer graft surface of the graft at the proximal end. A first proximal attachment mechanism releasably couples a second point on the proximal end of the prosthesis to the delivery catheter, wherein the second point is circumferentially spaced from the first point and a second proximal attachment mechanism releasably couples a third point on the proximal end of the prosthesis to the delivery catheter, wherein the third point is circumferentially spaced from the first point in one direction and from the second point in the opposite direction. The first and second proximal attachment mechanisms draw the second and third points to the first point to form three folds of graft fabric and wherein the folds extend about the delivery catheter in a folded configuration such that the outer surface of the graft at least partially wraps around the delivery catheter.

In another example a prosthesis delivery device is disclosed. The delivery device comprises a delivery catheter having a proximal end and a tubular prosthesis releasably coupled to the proximal end. The prosthesis has a proximal end, a distal end, a lumen extending between the proximal end and distal end, a sidewall of graft material, an inner graft surface, an outer graft surface and a fenestration formed in the sidewall of the prosthesis. The delivery catheter extends proximally through at least a portion of the prosthesis lumen and through the fenestration to a location external of the prosthesis and adjacent a first point on the outer graft surface at the proximal end of the prosthesis. A first proximal attachment mechanism releasably couples a second point on the proximal end of the prosthesis to the delivery catheter, wherein the second point is circumferentially spaced from the first point and a second proximal attachment mechanism releasably couples a third point on the proximal end of the prosthesis to the delivery catheter, wherein the third point is circumferentially spaced from the first point in one direction and circumferentially spaced from the second point in the opposite direction. The first and second proximal attachment mechanisms draw the second and third points to the first point to form first, second, and third folds of graft fabric and wherein the folds extend about the delivery catheter in a folded configuration.

In yet another example, a prosthesis delivery device is disclosed. The delivery device comprises a delivery catheter having a proximal end and a tubular prosthesis releasably coupled to the proximal end of the delivery catheter. The prosthesis has a proximal end, a distal end, and a lumen extending between the proximal end and distal end and a fenestration formed in a sidewall of the prosthesis. The delivery catheter extends proximally though at least a portion of the prosthesis lumen and through the fenestration formed in the side sidewallwall of the prosthesis. A first attachment mechanism releasably couples a second point at the proximal end of the prosthesis to the delivery catheter and a second attachment mechanism releasably couples a third point at the proximal end of the prosthesis to the delivery catheter. The first and second proximal attachment mechanisms have a first configuration in which the proximal end of the prosthesis is coupled to the delivery catheter and a second configuration in which the proximal end of the prosthesis is released from the delivery catheter.

BRIEF DESCRIPTIONS OF THE DRAWINGS

FIG. 1 shows an example of an introducer located within a vessel.

FIG. 2 shows an example of an introducer located within a vessel and an example of a branched stent graft deployed therein.

FIG. 3 shows the proximal end of the introducer of FIG. 2 with one example of a deployed branched stent graft having a catheter and a guide wire extending proximally through a portion of the stent graft and into a channel formed in the nose cone dilator.

FIG. 4 shows the proximal end of an introducer with one example of a deployed fenestrated stent graft having a catheter and a guide wire extending proximally through a portion of the stent graft and into a channel formed in the nose cone dilator.

FIG. 5 shows the introducer of FIG. 3 where the catheter and guide wire have been distally retracted out of the channel formed in the nose cone dilator.

FIG. 6 shows the introducer of FIG. 4 where the catheter and guide wire have been distally retracted out of the channel formed in the nose cone dilator and a secondary guide wire remains in a straight lumen of the nose cone dilator.

FIG. 7 shows an enlarged view of a nose cone dilator with a catheter and guide wire extending through a curved channel and a straight lumen extending through the nose cone.

FIG. 8 shows one example of a conventional introducer.

FIG. 9 shows an introducer with a deployed branched stent graft and a variable diameter dilator tip in an expanded-diameter configuration.

FIG. 10 shows the introducer of FIG. 9 with a deployed branched stent graft and a variable diameter dilator tip in a reduced-diameter configuration.

FIG. 11 shows another example of a variable diameter tip in a reduced-diameter configuration with a single resilient elongated member.

FIG. 11A shows another example of a variable diameter tip in a reduced-diameter configuration with two resilient elongated members.

FIG. 12 shows the variable diameter dilating tip of FIG. 11 in an expanded diameter configuration.

FIG. 13 illustrates a dilator and a delivery sheath that may be placed within a vessel during a procedure utilizing a cartridge technique.

FIG. 14 shows another example of an introducer with a peel-away sheath that may be tracked through the delivery sheath of FIG. 13 in a procedure utilizing a cartridge technique.

FIG. 15 shows an example of a stent graft coupled to the proximal end of an introducer and partially constrained by an introducer sheath.

FIG. 16 is a perspective view of the proximal end of the introducer with the stent graft releasably coupled to the introducer using a tri-fold configuration.

FIGS. 17-22 illustrate one example of a method for using two wires as a proximal attachment mechanism to create a tri-fold configuration at the proximal end of a stent graft to releasably couple the stent graft to the introducer.

FIG. 23 shows the introducer of FIG. 15 with the stent graft covered by a sheath and being tracked over a guide wire in a curved vessel.

FIG. 24 shows the introducer of FIG. 23 with the sheath fully withdrawn.

FIG. 25 shows the introducer of FIG. 24 with the proximal attachment wires removed to release the proximal tri-fold configuration and uncouple the proximal end of the stent graft from the introducer.

FIG. 26 shows an example of an introducer assembly with a sheath tapered radially inwardly at the proximal end to mate with a nose cone dilator.

DETAILED DESCRIPTION

The present disclosure relates to a delivery device or introducer for delivering a prosthesis such as a radially expandable stent graft within a human or animal body for repair of damaged vessels, ducts, or other physiological pathways and systems. In the present disclosure, the term “proximal” refers to a direction that is away from a physician during a medical procedure, while the term “distal” refers to a direction that is closest to the physician during the procedure. In addition, like reference numbers throughout the various drawings designate similar structure.

FIG. 1 shows an example of an introducer that has been tracked over a guide wire to a desired location within a curved vessel. In FIG. 1, the curved vessel 1 is the thoracic aorta. The thoracic aorta includes the ascending aorta 2 extending from the aortic valve 4 of the heart of the patient, the thoracic arch 6 and the descending aorta 8. Three branch arteries extend from the main artery (the thoracic arch 6) including the innominate artery 10, the left carotid artery 12 and the left subclavian artery 14. As shown, an aneurysm 16 has developed just distal of the left subclavian artery 14. The space 17 between the most proximal portion of the aneurysm 16 and the left subclavian artery 14 may, in some cases, be relatively short as shown in FIG. 1, and in other cases the space may be longer. Depending on the patient's unique anatomy and the location of the aneurysm 16, it may be necessary to extend the proximal end of a stent graft deployed in the vessel lumen 20 to an area or location that is proximal of the left subclavian artery 14 but distal to the left carotid artery 12. In doing so, blockage of some or all of the left subclavian artery 14 by the body of the stent graft may result. Accordingly, it may be advantageous to provide an introducer that is pre-loaded with a guide wire and a stent graft to facilitate cannulation of a branch vessel (such as the left subclavian artery 14) to therefore maintain/restore patency to the main vessel and branch vessels. As described herein, the stent graft carried on the introducer is preferably pre-cannulated with the guide wire. This single guide wire facilitates tracking of the introducer within a vessel, cannulation of the stent graft carried on the introducer and also allows cannulation of one or more of the branch vessels during use.

As partially shown in FIG. 1, an introducer 18 has been advanced into the lumen 20 of the vessel 1. In one example, the introducer 18 includes a retractable or removable sheath 22 and a secondary catheter 74. One or more guide wires 26 may extend through the lumen of the secondary catheter 74. The secondary catheter may be straight and/or it may have a curve imparted to a portion of it. For example, the secondary catheter 74 may be curved at a proximal end, with the curve of the secondary catheter generally corresponding to the outer or greater portion of the curve of the aortic arch 6.

The guide wire 26 may first be introduced into the vessel 1 and the introducer 18 then tracked over the guide wire 26 to a desired position within the vessel. Alternatively, the guide wire 26 may be pre-loaded within the secondary catheter 74 of the introducer, and thereby inserted into the vessel simultaneously with the introducer 18, or in yet a further example, the guide wire 26 may be inserted through the secondary catheter 74 of the introducer 18 and into the vessel 1 after the introducer has been at least partially positioned in the vessel 1. The introducer 18 also includes a nose cone dilator 28 extending proximally from the proximal end of the delivery catheter 66. The nose cone dilator 28 may be tapered and/or flexible to present an atraumatic tip.

As shown, the guide wire 26 extends through the secondary catheter 74 of the introducer 18, through at least a portion of the nose cone dilator 28 and has been extended further proximally to extend from the tip 30 of the nose cone dilator 28. As such, the guide wire 26 may facilitate tracking of the delivery device for placement, adjustment and movement of the delivery device 18 within the vessel 1. The proximal tip 32 of the guide wire 26 may have a curved (pig-tailed end) atraumatic tip so as not to pierce or damage the walls of the vessel lumen 20 and/or the aortic valve 4. The introducer 18 can be substantially straight or it may have a curved configuration imparted at its proximal end as described in U.S. Pat. No. 8,394,135, which is incorporated by reference herein. The nose cone dilator 28 also may be straight or curved, as shown in FIGS. 9 and 10 of U.S. Publication Application No. 2011/0125244 and in U.S. Pat. No. 7,611,529, which are both incorporated by reference herein. Prior to and during delivery of a prosthesis, such as a stent graft 34, the sheath 22 extends proximally to cover the stent graft 34 carried on introducer 18 to hold the stent graft in a radially inwardly contracted delivery configuration. The sheath 22 may extend proximally to cover at least the distal end of the nose cone dilator 28 as illustrated in FIG. 1.

FIG. 1 shows an example of an introducer 18 tracked over guide wire 26 to a location within a vessel 1, with the stent graft 34 still covered and held in a radially inwardly contracted delivery configuration by sheath 22. FIG. 2 shows the introducer of FIG. 1 within the vessel 1 after the sheath 22 has been distally retraced allowing the stent graft 34 to deploy from the introducer 18 and become expanded within the vessel 1 at the site of aneurysm 16. As shown, the stent graft 34 has a proximal end 36, a distal end 38, a proximal opening 40, a distal opening 42 and a tubular body 44 extending between the proximal 36 and distal 38 ends to define a graft lumen 52. The stent graft 34 may be a generally singular tube-like configuration with an internal branch 48 extending within the lumen 52 of the graft body 44 as illustrated in FIG. 2, although other configurations are also contemplated. For example, the stent graft 34 may be a fenestrated stent graft (wherein one or more openings or fenestrations are formed in the graft body 44) and/or a bifurcated stent graft (with first and second legs extending from the main graft body).

A series of stents 46 may be attached to the graft body 44 and extend along all of, or at least part of, the length of the stent graft 34. An exposed anchoring stent (not shown) with one or more barbs for attaching the stent graft to a vessel wall may extend from the proximal end 36 of the graft body 44 as described in U.S. Publication Application No. 2012/0277848, which is incorporated by reference herein. The stents 46 may be sutured to the graft material or held to the graft material in other known ways. The series of body stents 46 may be internal or external to the graft body 44, or both. For example, one of the stents 46 near the proximal end 36 and/or the distal end 38 of the stent graft 34 may be an internal sealing stent while the remaining body stents 46 are external to the graft body 44. Any one or more of the stents 46 may be provided with barbs that extend from the stent inside the tubular graft body, through the graft material to engage the vessel wall. Radiopaque markers (not shown) may be placed on various parts of the stent graft 34 to aid the user in positioning the stent graft during deployment.

Stents 46 may be zig-zag shaped as shown in FIG. 2, although other stent configurations are known and may be used alone or in combination with the zig-zag stents 46 and/or have other configurations as known in the art. The stents may be constructed of a self-expanding shape memory material, such as Nitinol, or they may be balloon expandable, or a combination of both depending on the particular characteristics desired of the stent graft.

As shown in FIG. 2, stent graft 34 is a branched stent graft that has been deployed in the aorta 1, having a series of self-expanding stents 46 extending along the length of the graft body 44. In this example, the branch 48 is an internal branch. In other words, the body 50 of the branch 48 extends within the lumen 52 of the stent graft 34. The branch 48 has a proximal end that extends from an aperture 56 formed in the sidewall of the graft body 44 and has a distal open end 54 that opens into lumen 52 of the stent graft 34.

FIG. 3 and FIG. 4 illustrate an introducer 18 with one example of a nose cone dilator 28 and a fully deployed stent graft 34. The nose cone dilator 28 has a distal end 58 and a proximal end 60 and a sidewall 62 extending between the proximal and distal ends. Nose cone dilator 28 may have a straight or substantially straight lumen 64 formed within and extending the length of the nose cone dilator 28 between the distal end 58 and proximal end 60. The straight lumen 64 may be configured to receive one or more guide wires and/or catheters there through. In one example, straight lumen 64 receives at least a proximal end of delivery catheter 66 but does not receive a guide wire. The delivery catheter 66 may be straight and/or it may have a curve imparted to a portion of it. For example, the delivery catheter 66 may be curved at a proximal end, with the curve of the secondary catheter generally corresponding to the outer or greater portion of the curve of the aortic arch 6.

Nose cone dilator 28 may also have a channel 68 formed within and extending through a portion of the length of the nose cone dilator 28 from the proximal end 60 and to the aperture 70 formed in the sidewall 62. The channel 68 may be at least partially curved and extend from the proximal end 60 of the nose cone dilator 28 and exit from the nose cone through the sidewall 62 of the nose cone dilator at aperture 70, as shown in FIG. 4. In one example, channel 68 may extend substantially longitudinally for a distance (i.e., substantially parallel to straight lumen 64) and then curve at its distal end to exit the sidewall 62 of the nose cone dilator 28 through aperture 70 at a location approximately midway between the proximal end 60 and distal end 58 of the nose cone dilator 28 as shown in FIGS. 3 and 4. However, the curved channel may exit the nose cone dilator 28 either closer to the proximal end 60 or closer to the distal end 58. In another example, the channel 68 may have a curve imparted to its entire length or may have a helical shape imparted to it.

In an alternative example (not shown), the curved channel 68 may be in the form of an elongated opening or slot extending from the aperture 70 formed in the sidewall 62 of the nose cone dilator 28 towards the proximal end 60. The channel or slot may be straight or curved or a combination thereof, and extend partially or, alternatively, extend all the way to the proximal end 60 of the nose cone dilator 28. In yet a further example, a groove (not shown) formed in the surface of the nose cone sidewall 62 may be used in place of the curved channel 68. The channel 68 (and/or slot or groove) may extend partially and/or fully in a proximal direction from a point of origination (such as aperture 70 and/or the beginning of the groove) towards the proximal end 60 of the nose cone. The channel 68 (or slot or groove) is preferably shaped and configured to receive at least a portion of the guide wire 26 and/or the secondary catheter 74 therein.

In another example, either alone or in combination with the above, a trigger wire (not shown) may also be provided to constrain the proximal tip of the guide wire 26 and/or the secondary catheter 74 against or within the nose cone dilator 28. More specifically, one or more trigger wires may be used to retain the guide wire 26 and/or the secondary catheter 74 within the curved channel 68 (or within the above-described alternatives, including the elongated opening, slot or groove formed in the nose cone dilator 28). The one or more trigger wires may pass over the secondary catheter 74 (and/or the guide wire 26 extending through the secondary catheter 74) at one or multiple points along its length and secure it to the nose cone dilator 28. Thus, when the trigger wire(s) is removed, the secondary catheter 74 (and guide wire 26) are freed from the nose cone dilator 28 and can then be manipulated by the user to make any necessary exchanges, including, but not limited to cannulating a side vessel (such as the left subclavian artery) extending from the aorta 1. When only trigger wire(s) are used to secure the secondary catheter 74 to the nose cone dilator 28 (and the secondary catheter 74 is not constrained within the curved channel 68 or above-described slot), it may not be necessary to distally retract the secondary catheter 74 to free it from a constrained configuration within the channel 68. Instead, removal of the trigger wire(s) will free the secondary catheter 74 from the nose cone dilator 28 so that it is available for further manipulation by the user.

Secondary catheter 74 can be preloaded with guide wire 26 extending there through. Alternatively, guide wire 26 may first be inserted into the vasculature and the introducer 18 then tracked over the guide wire 26, through secondary catheter 74, and into position within the vessel. In a non-limiting example, one procedure for introducing the introducer 18 into a patient is by means of the well-known Seldinger technique, in which a guide wire 26 is first inserted percutaneously into a patient's vasculature via a needle (not shown). The introducer 18 is inserted percutaneously and endoluminally into the patient, by tracking it over the guide wire 26, which acts to guide the introducer 18 through the vasculature up to the treatment site.

In one example, the straight lumen 64 and curved channel 68 create a ‘Y” shape within the nose cone dilator 28. In other words, as shown generally in FIGS. 5 and 6, the straight lumen 64 lies in a relatively straight line from the proximal end 60 to the distal end 58 of the nose cone dilator 28 and the curved channel 68 intersects the straight lumen 64 at some point between the proximal end 60 and the distal end 58 of the nose cone dilator 28 to generally form a “Y” configuration. In one example, the curved channel 68 intersects the straight lumen 64 about half way between the proximal end 60 and the distal end 58 of the nose cone dilator 28, although, the channel 68 may intersect the straight lumen 64 closer to the proximal end 60 and/or closer to the distal end 58 of the nose cone dilator 28.

As shown in FIGS. 3 and 4, the stent graft 34 carried by the introducer 18 can be pre-loaded with the guide wire 26. In one example, the guide wire 26 can extend proximally through the lumen 52 of the graft body 44, into the distal end 54 of the internal branch 48 and exit out of the branch 48 at proximal branch opening 56. The proximal tip 32 of the guide wire 26 can extend through channel 68 of the nose cone dilator 28 and into the proximal end 60 of the nose cone dilator 28. As shown in FIGS. 1 and 2, the guide wire 26 can, in use, be proximally advanced all the way out of the proximal end 60 of the nose cone dilator 28.

Secondary catheter 74 may be coaxial with at least a portion of the guide wire 26. In one example, the secondary catheter 74 is also pre-loaded within the introducer 18, such that the secondary catheter 74 is coaxial with and extends proximally over the guide wire 26, through the lumen 52 of the graft body 44, into the distal end 54 of the internal branch 48. The secondary catheter 74 then exits out of the branch 48 at proximal branch opening 56. As FIG. 2 shows, the proximal end 76 of the secondary catheter 74 can be tucked into and held within the curved channel 68 of the nose cone dilator 28. As shown in FIGS. 3 and 4 (and shown in greater detail in FIG. 7) the curved channel 68 (168 of FIG. 7) may have a substantially constant inner diameter along its length, and near the proximal end 60 of the nose cone dilator 28, the inner diameter of the channel 68 (168) becomes narrowed at point 69. In this way, the secondary catheter 74 (174) can advance proximally through the channel 68 (168) to the proximal end 60 of the nose cone dilator 28 but it cannot advance through the narrowed inner diameter portion 69 of the channel 68. While the guide wire 26 (126) may pass through the narrowed diameter portion 69 of the channel 68, the secondary catheter 74 cannot pass through this narrowed diameter portion 69 of the channel 68 and is therefore prevented from extending proximally out of the proximal tip 30 (130) of the nose cone dilator 28.

As shown partially in FIG. 1, the delivery catheter 66 may extend proximally from an external manipulation handle section or distal end of the introducer 18 (identified as reference number 100 in FIG. 8) through the lumen 52 of the graft body 44 and into the straight lumen 64 of the nose cone dilator 28 to secure the nose cone dilator 28 to the proximal end of the delivery catheter 66. The delivery catheter 66 may terminate within the lumen 64 near the distal end 58 of the nose cone dilator 28, or alternatively, the delivery catheter 66 may extend further into the lumen 64 and terminate at a point closer to the proximal end 60 of the nose cone dilator 28.

As shown in FIGS. 1 and 2, the guide wire 26 advantageously serves as a means to track the introducer 18 to a desired location within the vessel 1 while also pre-cannulating the branch 48 of the stent graft 34 with a single wire 26. In other words, introduction of the introducer and cannulation of the branch 48 may be combined through the use of a single guide wire 26, and this same guide wire may then be further manipulated during use to cannulate one or more branch vessels extending from the main vessel.

In one example, as FIG. 1 shows, a guide wire 26 can be inserted percutaneously and advanced proximally through a vessel. Next, the introducer 18 containing a prosthesis (such as a stent graft 34 held in a radially compressed delivery configuration under a sheath 22) can be advanced over the guide wire 26. When the prosthesis is in a deployment position within a vessel lumen 52, the sheath 22 can be withdrawn and the stent graft 34 can be deployed by one or more known methods. For example, following sheath retraction, one or more trigger wires or diameter reducing ties (wires 442, 444 described in detail below in connection with FIGS. 15-25) at the proximal end 36 of the stent graft 34 and/or the distal end 38 of the stent graft, or both ends, can be removed allowing the stent graft 34 to radially outwardly expand and deploy from the introducer 18. With the secondary catheter 74 and/or the delivery catheter 66 having a curve imparted to at least a proximal end or portion of it (which curve generally corresponds to the outer curve of the aortic arch 6) the secondary catheter 74 and/or the delivery catheter 66 tend to sit adjacent to or on the greater curve of the aorta. With the stent graft 34 properly aligned with any one or more of the desired branch vessel(s), the stent graft 34 will preferably open away from the delivery catheter 66 as it is unsheathed during deployment, further guaranteeing proper orientation within the vessel.

FIG. 4 and FIG. 6 show an example of the proximal end of an introducer 18 with another example of a stent graft 78 carried on the introducer 18. The stent graft shown in FIGS. 4 and 6 is a fenestrated stent graft 78 that has been deployed within a vessel 1. Fenestrated stent graft 78 has at least one fenestration or opening 80 formed in the sidewall of the graft body 44, but may not have the internal branch 48 as does the stent graft 34 shown in FIGS. 3 and 5. A guide wire 26 can be threaded proximally through the lumen 52 of the graft 78 and extended out of the lumen 52 through the fenestration 80. The proximal tip 32 of the guide wire 26 can then be threaded into and through the curved channel 68 of the nose cone dilator 28 as shown in FIG. 4. The guide wire 26 can advance into the proximal end 60 of the nose cone dilator 28 and be further advanced proximally all the way out of the proximal end 60 of the nose cone dilator 28.

As also shown in FIG. 4, the secondary catheter 74 is coaxial with at least a portion of the guide wire 26. In one example, the secondary catheter 74 is pre-loaded within the introducer 18, such that the secondary catheter 74 extends proximally over the guide wire 26 and through the lumen 52 of the graft body 44, and exits out of the graft lumen 52 through fenestration 80. The proximal end 76 of the secondary catheter 74 can be tucked into and held within the curved channel 68 of the nose cone dilator 28. The secondary catheter 74 can advance towards the proximal end 60 of the nose cone dilator 28 but it cannot advance all the way out of the proximal end 60 of the nose cone dilator 28 due to the narrowed inner diameter portion 69 of the channel 68. Like FIGS. 1-3, the guide wire 26 of FIGS. 4 and 6 also advantageously serves as a means to track the introducer 18 to a desired location within the vessel while also pre-cannulating the fenestration 80 with a single wire 26. In other words, the stent graft 78 is pre-cannulated within the introducer by the guide wire 26 (i.e., the wire extends through the graft lumen and fenestration 80), and in addition, the guide wire allows the introducer to be tracked into place within a vessel while also allowing the wire to be manipulated in use to cannulate a branch vessel, as described below.

FIGS. 5 and 6 show the guide wire 26 and secondary catheter 74 retracted partially distally. The proximal tip 32 of the guide wire 26 has been withdrawn distally from the nose cone dilator 28. In addition, the secondary catheter 74 has been retracted distally so that it is no longer constrained within the channel 68 of the nose cone dilator 28. In this configuration, the user is free to manipulate the guide wire 26 and/or the secondary catheter 74 to make any necessary exchanges, such as, for example, to cannulate one or more of the branch vessels (such as the left subclavian artery, left carotid and/or innominate artery) extending from the main vessel 1 as described generally below.

In one non-limiting example of use, the introducer 18 may be tracked over guide wire 26 to a desired stent graft position within a vessel 1 as shown in FIG. 1. The sheath 22 can then be distally retracted to expose the stent graft 34 (or stent graft 78 of FIGS. 4 and 6) and any trigger wires or diameter reducing ties removed (such as wires 442, 444 described below in connection with FIGS. 15-25) to allow the stent graft to release from the introducer 18 and deploy within the vessel 1. At this time, it may be desirable to cannulate a branch vessel, such as the left subclavian artery 14, left carotid artery 12 and/or innominate artery 10, extending from the main vessel 1. To do so, the user may distally retract the guide wire 26 and secondary catheter 74. This retraction will free guide wire 26 and secondary catheter 74 from the curved channel 68 in the nose cone dilator 28 as shown in FIGS. 5 and 6. When the proximal end 76 of secondary catheter 74 is freed from the channel 68, the guide wire 26 may then be manipulated by the user to cannulate a desired branch vessel. For example, the user may advance the guide wire 26 proximally and extend it into, and thereby cannulate the left subclavian artery 14. If necessary or desired, a secondary stent graft, such as an extension stent graft (not shown) loaded on to a secondary introducer (not shown) may be tracked over the guide wire 26 and into the cannulated branch vessel to deliver and deploy the extension branch therein, thus restoring and/or maintaining patency to the branch vessel.

FIG. 6 shows another example of an introducer 18 with a stent graft 78 deployed from the proximal end of the introducer 18. The guide wire 26 and secondary catheter 74 have been retracted distally out of the channel 68 in the nose cone dilator 28. In one non-limiting example shown in FIG. 6, the nose cone dilator 28 may have a straight lumen 64 extending between the proximal end 60 and distal end 58, configured to receive a secondary guide wire 82 there through. If desired, the secondary guide wire 82 can be advanced through the straight lumen 64 and be extended out of the proximal end 60 of the nose cone dilator 28. In doing so, the nose cone dilator 28 will still have a guide wire 82 extending there through to reinforce and constrain the positioning of the nose cone dilator 28 within the vessel lumen, while also maintaining a pathway for the introducer to be tracked over, even after guide wire 26 and/or secondary catheter 74 has been partially or fully withdrawn from the body.

FIG. 7 shows an enlarged view of the nose cone dilator 128 with a channel or lumen 168 extending there through. As previously described, the nose cone dilator 128 has channel 168 that extends from the proximal end 160 of the nose cone dilator 128 and terminates at aperture 170 formed in a sidewall 162 of the nose cone dilator. Curved channel 168 can be configured to receive a guide wire 126 and a secondary catheter 174 therein. As shown in FIG. 7, the channel 168 may have a substantially constant inner diameter along its length, and near the proximal end 160 of the nose cone dilator 128, the inner diameter of the channel 168 becomes narrowed at location 169. In this way, the secondary catheter 174 can advance proximally through the channel 168 to the proximal end 160 of the nose cone dilator 128 but it cannot advance through the narrowed inner diameter portion 169 of the channel 168. While the guide wire 126 may pass through the narrowed diameter portion 169 of the channel 168, the secondary catheter cannot pass through this narrowed diameter portion 169 of the channel 168 and is therefore prevented from extending proximally out of the proximal tip 130 of the nose cone dilator 128.

FIG. 8 shows another example of a conventional introducer assembly 200. Introducer assembly 200 has a dilator tip 202 at its proximal end 210 and an external manipulation section or handle at the distal end 100. A flexible delivery catheter 216 extends from a location distal to the handle 100 to the dilator tip 202. Although this introducer 200 can be used in any area of the vasculature, it is described here as being used in the aortic arch.

As FIG. 8 and FIG. 9 show, an implantable prosthesis, such as a stent graft 224, is carried on the delivery catheter 216 at the proximal end. A retractable introducer sheath 206 retains the stent graft 224 in a radially inwardly contracted delivery configuration on the delivery catheter 216 and can be retracted during deployment. The introducer 200 typically includes a pusher member 208 coaxial with at least a portion of the delivery catheter 216. The pusher member 208 extends proximally from the distal end or handle portion of the introducer and terminates at a location distal to the stent graft 224. In one example, the introducer assembly 200 includes a guide wire 220 which passes through the delivery catheter 216 and the dilator tip 202. In use, the introducer 200 can be tracked over the guide wire 220 to a desired location within the vasculature during the delivery and deployment procedure.

The delivery catheter 216 may extend proximally through the lumen 218 of the stent graft 224 to the dilator tip 202. In another example, where a fenestrated stent graft is used (such as the fenestrated stent graft 44 shown in FIG. 4), the delivery catheter 216 may extend into the distal end of the stent graft, then outwardly through the fenestration 80 formed in the sidewall of the graft and continue proximally to the dilator tip 202. In yet another example, where a branched stent graft is used (as shown in FIG. 9), the delivery catheter 216 may extend proximally into the distal end 228 of the stent graft 224, through the lumen of the internal graft branch 232 and continue out of the branch to the dilator tip 202.

The dilator tip 202 is preferably tapered and smooth, thereby facilitating atraumatic tracking and guiding of the introducer 200 through tortuous vasculature to a desired location within a vessel. In one example, the dilator tip 202 has a variable diameter. For example, the dilator tip 202 may be radially outwardly expanded, either partially or fully, during delivery of the stent graft 224. More specifically, when dilation is required, such as during insertion of the introducer 200 into a patient, the tip may be partially expanded, or alternatively, fully expanded, so that the outer diameter of the dilator tip 202 is at its maximum size. The introducer 200 may then be tracked to its desired position within the vessel. After graft deployment, the dilator tip 202 may be reduced in diameter to a smaller, radially inwardly contracted configuration. With the outer diameter of the dilator tip 202 reduced, the tip 202 can be retracted distally through the stent graft 224 for removal from the vessel.

In another example, where the delivery catheter 216 extends through a fenestration and/or side branch of the stent graft (such as, for example, the fenestration 80 formed in the sidewall of the graft body 44 of FIG. 4 and/or the branch 232 of the stent graft body 230 shown in FIG. 9), the reduction of the diameter of the dilator tip 202 advantageously facilitates retraction and withdrawal of the tip 202 through the lumen 218 of the stent graft body 230 and through the fenestration and/or through the graft side branch 232, while reducing the risk of the tip 202 snagging on any portion of the stent graft (including the fenestration and/or the graft side branch 232) or from snagging on any other portion of the introducer 200 during retraction of the dilator tip 202 out of the body. If desired, the guide wire 220 may be left in place within the main vessel 1, such as for further manipulation by the user to cannulate one or more branch vessels 10, 12 and/or 14, and then retracted at a later time during a procedure

FIG. 9 shows an introducer 200 with a deployed branched stent graft 224 and a variable diameter dilator tip 202 in a radially outwardly expanded-diameter configuration. FIG. 10 shows the introducer 200 of FIG. 9 with a deployed branched stent graft 224 and a variable diameter dilator tip 202 in a radially inwardly contracted or reduced-diameter configuration. The dilator tip 202 shown in FIGS. 9 and 10 may be a balloon-like resilient element constructed of a material having radially expandable and contractible properties. For example, the dilator tip 202 may be formed of polyurethane, nylon, PEBAX® (polyether block amide), PVC, plastics, rubbers and/or other resilient materials or a combination thereof. The tip 202 may have a substantially conical shape, spherical shape or onion shape to facilitate atraumatic insertion in a body lumen. The diameter of the outer surface of the dilator tip 202 may vary along its longitudinal length. For example, the tip 202 may have a proximal taper and/or a distal taper, with the center portion of the tip 202 having a greater diameter than the proximal and distal tapered portions when the tip 202 is in both the expanded condition and the contracted condition. A lumen extends through the dilator tip 202 between its proximal end 212 and distal end 214. The guide wire 220 extends proximally through the lumen of the delivery catheter 216 and can be extended through the lumen of the dilator tip 202.

FIG. 9 illustrates the proximal end of an introducer 200 with a branched stent graft 224 in a radially outwardly deployed configuration. The stent graft 224 may have a proximal end 226, distal end 228 and a tubular graft body 230 extending there between. One or more stents 234 may be attached to the tubular graft body 230. Branched stent graft 224 may have a proximal branch opening or aperture 236 located near the proximal end 226 of the stent graft 224. An internal graft branch 232 extends distally from the branch opening 236 within the lumen 218 of the stent graft 224. The dilator tip 202 and delivery catheter 216 may extend through the lumen 218 of branched stent graft 224. In one example shown in FIG. 9, the delivery catheter 216 and dilator tip 202 extend proximally through the lumen 218 of the stent graft 224, into the distal opening 238 of the branched stent graft 224 and exits the graft 224 through the proximal branch opening 236. Although not shown, in another example, a fenestrated stent graft can be used instead of a branched stent graft, and the delivery catheter 216 would pass out of the fenestration instead of through the branch opening.

As mentioned above, the dilator tip 202 is moveable between a radially outwardly expanded-diameter configuration (FIG. 9) and a radially inwardly reduced-diameter configuration (FIG. 10). During insertion of the introducer 200 into a patient, dilator tip 202 can be in an at least partially expanded configuration. Once a user has tracked the introducer 200 into a desired location and deployed the stent graft 224, the outer diameter of the dilator tip 202 may be reduced to a smaller diameter contracted configuration. The dilator tip 202 and delivery catheter 216 may then be withdrawn from the patient by pulling distally on the cannula, such as by retracting handle 100 as FIG. 10 illustrates.

Several different mechanisms can be used to control the variable diameter of the dilator tip 202. In one example, the dilator tip 202 has an inner cavity which can be filled with fluid, gel and/or gas as shown and described in U.S. Publication Application No. 2012/0109056, which is incorporated by reference herein. Another mechanism to control the diameter of the dilator tip 202 is by mechanical means. In one example, a flexible outer surface 240 covers an expandable structure such as, for example, a series of members, fingers, cages, mesh and the like which can be mechanically expanded and contracted. As the structure is expanded and contracted, the flexible outer surface 240 radially expands and contracts along with it, thus providing the user with control over the diameter of the dilator tip 202.

FIG. 11 shows one example of a mechanically expandable variable diameter dilator tip 202 in a reduced-diameter configuration. FIG. 12 shows the variable diameter dilator tip 202 of FIG. 11 in an expanded-diameter configuration. For the sake of clarity, a flexible outer 240 surface has been omitted from FIGS. 11 and 12 so that the internal structure can be observed and described.

As shown in FIGS. 11 and 12, the delivery catheter 216 extends distally from the distal end 214 of the dilator tip 202. At least one biasing member 242 is disposed within the center of dilator tip 202 and can extend longitudinally from the proximal end 212 to the distal end 214 of the dilator tip 202. In one example, the biasing member 242 is a coil spring. One or more collars 244 may extend circumferentially around and crimp down the proximal and distal ends 212, 214 of the dilator tip 202 and a hub 246 may be secured to the collar 244.

Extending around the biasing member 242 between the proximal and distal ends 212, 214 of the tip 202 is an expandable and contractible structure 248. The structure 248 may be comprised of one or more fingers, wires, coils, fabrics, fibers, flexible arcuate members, cages, screens, disks, walls and the like, and may be constructed or formed from a single material or, alternatively, may be formed from a variety or combination of materials. In one example, at least a portion of structure 248 may be formed of any suitable material that may be expanded, such as by mechanical expansion. In other examples, at least a portion of the structure 248 may be formed from any suitable material that will result in self-expansion, such as shape memory material. As shown in FIGS. 11 and 12, the structure 248 is a mesh. A flexible outer surface or member 240 (shown in FIGS. 9 and 10 but removed from FIGS. 11, 11A and 12) may cover the mesh structure 248.

Dilating tip 202 can be mechanically expanded and contracted such that the outer diameter of the dilating tip 202 can increase and decrease. Such radial outward expansion of the tip 202 may be achieved in several ways. First, in one example, one or more resilient inner central elongate member(s) 242 extends between the proximal and distal hubs 246 as shown in FIGS. 11 and 12. The central elongate member 242 may include a coiled member or spring that extends substantially along the longitudinal axis. A proximal end of the elongate member 248 may be secured to the proximal hub 246 and a distal end of the elongate member may be secured to the distal hub 246.

The mesh structure 248 extends radially outwardly at a location that is generally centered between the respective hubs 246 to form a substantially conical, elliptical, ovoidal or egg-shape. The elongate member 248 may be biased in either an expanded condition or a contracted condition, thereby biasing the tip 202 in either a diameter-reduced condition or a diameter-expanded configuration, respectively. The elongate member 248 is also preferably longitudinally extensible such that it can be lengthened or stretched to facilitate a radially constricted reduced-diameter configuration as shown in FIG. 11. When the respective hubs 246 are extended away from each other in substantially opposing directions, the central elongate member 242 is extended. As a result, the dilator tip 202 becomes radially inwardly contracted. When the respective hubs 246 are moved towards each other, the central elongate member shortens. As a result, the dilator tip 202 becomes radially outwardly expanded as shown in FIG. 12.

In another example, as shown generally in FIG. 11A, radial outward expansion of the dilator tip 202 may be achieved by providing two separate inner central elongate members, namely proximal elongate member 242 a and distal elongate member 242 b coupled to each of the respective hubs 246. The two central elongate members 242 a and 242 b may be in the form of springs or coils, or alternatively, two correspondingly shaped threaded members, one of which is configured to receive the other in a threadedly engaging manner. The two elongate members 242 a and 242 b preferably extend from each of the respective hubs 246 towards each other to a point where their respective terminating ends are adjacent and/or abut, and are capable of otherwise engaging each other. One of the elongate members 242 b extending from the distal hub 246 may be rotated relative to the other elongate member 242 a. Such rotation may be achieved by rotation of the delivery catheter 216 by the user, which, in turn, causes rotation of the distal elongate member 242 b. Rotation of the distal elongate member 242 b causes the two elongate members to engage each other (such as by one elongate member threadedly engaging the other elongate member) which, in turn, pulls the respective hubs 246 towards each other along the longitudinal axis. As the hubs 246 are pulled towards each other, the woven mesh 248 becomes extended radially outwardly at a location generally between the respective hubs 246 to form a radially outwardly expanded-diameter dilator tip 202 as illustrated in FIG. 12. Similarly, rotation of distal elongate member 242 b (such as by rotation of the delivery catheter 216 in the opposite direction) causes the elongate members 242 a and 242 b to unthread or otherwise disengage, thus moving the respective hubs 246 longitudinally away from each other, such that dilator tip 202 may be returned to a radially-inwardly reduced-diameter configuration, as illustrated in FIGS. 11 and 11A. Expansion and contraction of the variable diameter tip 202 is further described in U.S. application Ser. No. 14/293,536, which is incorporated by reference herein.

In yet another example, FIG. 13 illustrates an introducer 300 that can be tracked into place within a vessel for delivery and deployment of a branched and/or fenestrated stent graft. The stent graft may be tracked into place and also pre-cannulated by the use of only a single wire. This may be achieved by utilizing an adaptation of a “cartridge” technique. This technique may be performed using a peel-away introducer sheath. FIG. 13 shows an example of an introducer 300 with a peel-away introducer sheath 304 for delivering and deploying a stent graft 310 using an adapted cartridge technique.

A guide wire 306 can first be inserted percutaneously into a patient's vasculature via a needle by known techniques. A delivery sheath 316, coaxial with a dilator of sufficient size 303, can be tracked over the guide wire 306 to the desired location in the vessel. The dilator 303 may have a nose cone 308 at its proximal end to provide an atraumatic tip for navigating the dilator 303 to a desired location within a vessel. The dilator 303 with the nose cone 308 at its proximal end can then be removed from the vasculature, leaving the sheath 316 in place. Sheath 316 can then serve as a conduit through which introducer 300 can be inserted.

A stent graft 310, loaded on the proximal end of a delivery catheter 302 and constrained under a peel-away sheath 304, can then be inserted in and through a hemostatic valve (not shown) near the distal end (not shown) of the delivery sheath 316 and pushed forward or proximally through the delivery sheath (such as by a pusher catheter 305) to the intended deployment location within a patient's vasculature. Once there, a user can push the stent graft proximally and out of the proximal end of the peel away sheath 304 using pusher 305, or alternatively, the user may remove the peel-away sheath 304 (distally) from the stent graft 310 by using the ends 312 of the peel-away sheath 304 as handles and pulling them distally so that the peel-away sheath 304 separates longitudinally and splits at the distal end 314. Next, a user can then distally pull (withdraw) the pull-away sheath 304 allowing the stent graft 310 to radially outwardly expand and deploy within the vessel.

Thus, when the stent graft 310 (loaded on the delivery catheter 302 within the peel-away sheath 304) is inserted through the delivery sheath 316 that has already been tracked into place within the vessel, a second guide wire and dilator tip may be eliminated. In other words, the delivery sheath 316 provides a conduit through which the delivery catheter 302 may be inserted, thus, the need for another wire and/or dilating tip may be unnecessary. Alternatively, the introducer 300 may comprise a stent graft 310 (such as a branched stent graft 34 or a fenestrated stent graft 78 as described above) that is pre-loaded with a wire 318 so that once the stent graft 310 has been tracked to the desired location within a vessel and removed from the peel away sheath 304, the wire 318 may be manipulated by the user to cannulate one or more branch vessels extending from the main vessel 1.

In one example, the introducer assembly 300 is used in the aortic arch. The stent graft may be a singular tube, a fenestrated stent graft or a branched or bifurcated stent graft. The wire 318 can be passed through a branch or fenestration of the stent graft 310 as generally described above. Once the stent graft 310 is deployed, the guide wire 318 will be in place to perform any necessary cannulation of a branch vessel extending from the main vessel. In this way, the introducer 300 can be tracked into place within delivery sheath 316 and the stent graft branch and/or fenestration may also be pre-cannulated by the use of only a single wire.

In yet another example, FIG. 15 illustrates the proximal end of a delivery device or introducer assembly that can be tracked into place within a vessel to deliver and deploy a pre-cannulated branched and/or fenestrated stent graft. The wire used to track the device into place may be the same wire that is used to pre-cannulate the stent graft as well as the wire used to cannulate a branch vessel extending from the main vessel, as will be described in further detail below. The delivery device or introducer assembly may, in one example, be like that shown in FIG. 8, for delivering a prosthesis such as stent graft 34, 78 and/or 224 described above, or may be any other suitable introducer assembly chosen by one of skill in the art for use in a procedure.

The introducer may be pre-loaded with a guide wire that may be used to track the introducer into place within a vessel, with the same guide wire also pre-cannulating a side branch and/or fenestration formed in the stent graft. In other words, introduction of the introducer and cannulation of the internal graft branch or fenestration may be combined through the use of a single guide wire, and this same guide wire may then be further manipulated during use to cannulate one or more branch vessels extending from the main vessel 1, including but not limited to the innominate artery 10, the left carotid artery 12 and/or the left subclavian artery 14.

FIG. 15 shows an example of an introducer assembly 400 for delivering and deploying a stent graft 404. In FIG. 15, an introducer sheath 402 has been partially retracted, allowing the proximal end of the stent graft 404 to be exposed. The proximal end 438 of the stent graft 404 is releasably coupled to the introducer, and in FIG. 15, the proximal end 438 of the stent graft is retained in a radially inwardly contracted delivery configuration by one or more proximal fixation mechanisms or diameter reducing ties as will be described in further detail below. The distal end of the stent graft 404 may also be coupled to the introducer, and if desired, the stent graft 404 may be coupled to the introducer at one or more additional points along the main body of the stent graft between the proximal and distal ends.

Delivery of the stent graft 404 to the targeted location within a vessel can be accomplished using a single guide wire. A guide wire 406 can first be inserted percutaneously into a patient's vasculature via a needle by known techniques. Next, the introducer assembly 400 can inserted into the patient's vasculature and tracked over the guide wire 406. Alternatively, the introducer assembly 400 can be inserted over the guide wire simultaneously with the guide wire 406 being tracked into place within a vessel.

An introducer sheath 402, coaxial with a stent graft 404 coupled to the proximal end of a delivery catheter 412 (and constrained under sheath 402) can be tracked over the guide wire 406 (through delivery catheter 412) to the intended deployment location within a patient's vasculature. The introducer sheath 402 may extend proximally over the stent graft 404 to the distal end 440 of a nose cone dilator 408. The nose cone dilator 408 may have a tapered atraumatic proximal tip for navigating to a desired location within a vessel. Once there, a user can then distally retract the sheath 402, thus allowing the stent graft 404 to radially outwardly expand and at least partially deploy within the vessel. After sheath retraction, the proximal end of the stent graft 404 may still be releasably coupled to the delivery catheter 412 by the tri-fold proximal fixation mechanism 446 (as well as one or more additional points between the proximal end and distal end of the stent graft may also still be releasably coupled to the delivery catheter 412) as described below.

The stent graft 404 may comprise a branched stent graft 34 or a fenestrated stent graft 78 as described above, or may be any other stent graft configuration as necessary or desired depending on the particular vessel(s) being treated and the procedure being performed. For exemplary purposes, the stent graft 404 as described further below is identified as a branched stent graft having an internal side branch 414, but it would be recognized that the stent graft 404 may be any of the above-mentioned configurations or combinations thereof. The stent graft 404 may be pre-loaded with the guide wire 406, so that once the stent graft 404 has been tracked to the desired location within a vessel, the guide wire 406 may be manipulated by the user to cannulate one or more branch vessels extending from the main vessel. In one example, the introducer assembly 400 may be used to deliver a stent graft into the aortic arch and the branch vessel extending from this main vessel 1 may be the left subclavian artery 14, for example. The guide wire 406 can be passed through the lumen of a side branch (such as internal branch 414) and/or fenestration (such as aperture 424) of the stent graft 404 as generally described above. Once the stent graft 404 is deployed, the guide wire 406 will be in place to perform any necessary exchanges including cannulation of a branch vessel extending from the aortic arch. In this way, the guide wire 406 advantageously serves as a means to track the introducer assembly 400 to a desired location within the vessel 1 while also pre-cannulating the internal branch 414 or aperture 424 of the stent graft 404 with a single guide wire 406. In other words, introduction of the introducer assembly and cannulation of the internal graft branch (or fenestration) may be combined through the use of a single guide wire 406, and this same guide wire may then be further manipulated during use to cannulate one or more branch vessels extending from the main vessel.

As partially shown in FIG. 15, stent graft 404 has been partially deployed because introducer sheath 402 once constraining it has been partially withdrawn, allowing the proximal end 438 of stent graft 404 to be unconstrained from the sheath 402. In this example, stent graft 404 is a branched stent graft having a series of self-expanding stents 416 extending along the length of the graft body 426. In this example, the branch 414 is an internal branch. In other words, the body 420 of the branch 414 extends within the lumen 422 of the stent graft 404. The branch 414 has a proximal end 418 with a proximal opening 432 that extends from an aperture 424 formed in the sidewall of the graft body 426 and has a distal open end 428 that opens into lumen 422 of the stent graft 404.

As shown in FIGS. 15 and 25, the stent graft 404 carried by the introducer assembly 400 can be pre-loaded with the guide wire 406. In one example, the guide wire 406 can extend proximally through the lumen 422 of the stent graft 404, into the distal end 428 of the internal branch 414 and exit out of the branch 414 at the proximal branch opening 432. The proximal tip 434 of the guide wire 406 can extend through a channel or lumen (not shown) in the dilator 408. As shown in FIG. 25, the proximal tip 434 of the guide wire 406 can, in use, be proximally advanced all the way out of the proximal end 436 of the dilator 408.

FIGS. 17 and 24 illustrate the introducer assembly 400 of FIG. 15 when the introducer sheath 402 has been fully retracted by a user, but the stent graft 404 is not yet fully deployed because the proximal end 438 of stent graft 404 is still releasably attached or coupled to the delivery catheter 412 by one or more proximal attachment mechanisms and/or diameter reducing ties. In one example, as illustrated in FIG. 16, the proximal end 438 of stent graft 404 is releasably coupled or tied to the delivery catheter 412 at the distal end 440 of the dilator 408 and/or at the proximal end 452 of the delivery catheter 412. In one example, the proximal end 438 of stent graft 404 is tied to the delivery catheter 412 using at least two wires (first wire 442 and second wire 444) to create a proximal tri-fold 446 in the graft body 426. In addition to the proximal attachment, the stent graft 404 may also be releasably coupled or tied to the delivery catheter 412 at one or more additional points along the graft body 426 of the stent graft 404 between the proximal end 438 and distal end.

The delivery catheter 412 may be stiff enough to allow it to be pushed within a vessel lumen without collapsing, yet resilient or otherwise flexible enough to navigate the tortious vasculature. The delivery catheter 412 may be substantially straight or it may have a curve imparted to at least a portion of it. For example, as shown in FIGS. 15, 16, 24 and 25, the proximal end 452 of the delivery catheter 412 may be bendable to conform to the curve of the aorta as it is tracked into place. Alternatively, the proximal end 452 of the delivery catheter 412 may be pre-curved so that it automatically conforms to the curve of the aortic arch 6 during delivery and deployment. As will be described in further detail below, and as shown in FIGS. 16, 24 and 25, the delivery catheter 412 extends through at least a portion of the stent graft lumen 422 and exits the lumen 422 through the proximal branch opening 432. The proximal end 452 of the delivery catheter 412 then extends through aperture 424 and runs along the outside or external surface of the graft body 456 adjacent a first point 466 at the proximal end of the stent graft 404 as shown generally in FIGS. 16 and 19.

With the delivery catheter 412 having a curve imparted to at least a proximal end or portion of it, the delivery catheter thereby tends to sit adjacent to or on the greater curve of the aorta as shown in FIGS. 24 and 25. In other words, the proximal end 452 of the delivery catheter that runs along the outside surface of the graft body 456 and adjacent to a first point 466 at the proximal end of the stent graft 404 may be sandwiched between the outer surface of the graft body and the inner surface of the vessel wall within the aorta when then stent graft 404 is unsheathed during delivery and deployment, as shown in connection with FIG. 25. With the stent graft 404 properly aligned with any one or more of the desired branch vessel(s), and with the stent graft 404 releasably attached to the delivery catheter at the proximal end 438 (and/or attached at any one or more points along the graft body 426 between the proximal and distal ends of the stent graft 404), the stent graft 404 will preferably open away from the delivery catheter 412 (i.e., the stent graft 404 will expand downwardly and away from the delivery catheter 412). Because the delivery catheter 412 extends along the greater curve of the vessel, the delivery catheter 412 serves as a “spine” for the stent graft 404, to thereby maintain the position of the stent graft 404 (and the position of the internal branch 414, the aperture 424 and/or proximal branch opening 432) and properly align the stent graft 404 with the greater curve of the vessel as it is unsheathed during deployment, further guaranteeing proper orientation of the stent graft 404 within the vessel. Advantageously, with the delivery catheter 412 serving as a “spine” that is releasably attached to at least the proximal end 438 (and which may also be releasably attached to one or more additional points along the graft body 426) maintains or assures rotational alignment of the stent graft 404, ultimately facilitating alignment with and/or cannulation of the one or more branch vessels extending from the main vessel 1, including but not limited to the left subclavian artery 14. Full deployment of the stent graft 404, including release of the one or more proximal attachment mechanisms or wires is described in further detail below.

FIGS. 17-21 illustrate a series of method steps in which at least two wires may be manipulated to tie and releasably couple the proximal end 438 of graft body 426 into the tri-fold configuration 446 shown in FIG. 16. As seen in FIG. 17, first wire 442 has a proximal end 448 and second wire 444 has a proximal end 450. The first wire 442 and second wire 444 may be disposed within the lumen of the delivery catheter 412 and may extend proximally from the distal end (not shown) of the delivery catheter 412 and exit the proximal end 452 of delivery catheter 412 through one or more holes or apertures 454 formed in the delivery catheter 412.

In one example, first wire 442 and second wire 444 exit the proximal end 452 of delivery catheter 412 just distal to the distal end 440 of dilator 408. The proximal end 448 of first wire 442 and the proximal end 450 of second wire 444 may be threaded from the apertures 454 at a location outside of graft body 456, threaded through graft body 426 at the proximal end 438 of the stent graft 404 and into the lumen 422 of the stent graft, as shown in FIG. 17. Next, as seen in FIG. 18, first wire 442 may be threaded from the inside of graft body 458 through the graft body 426 at a second location or point 462 to outside of the graft body 456. In one example, first wire 442 may be threaded through the graft body 426 at a second location or point 462 that is approximately one-third of the circumference around the proximal end 438 of stent graft 404 from the first point 466. Next, first wire 442 may be threaded back into the lumen 422 inside of the graft body 458 at or near the second point 462. Similarly, the second wire 444 may be threaded from the inside of graft body 458 through the graft body 426 to the outside of the graft body 456. In one example, second wire 444 may be threaded at a third point or location 464 approximately two-thirds of the circumference around the proximal end 438 of stent graft 404 (or, in other words, the third point 464 is circumferentially spaced from the first point 466 in one direction and from the second point 462 in the opposite direction. Next, second wire 444 may then be threaded back into the graft body near the third point 464 to the inside of graft body 458 as shown in FIG. 18.

As seen in FIGS. 19 and 20, the proximal ends 448, 450 of the first wire 442 and second wire 444, respectively, are now both located within the stent graft lumen 422 and may be pulled taut to draw the graft body 426 radially inwardly towards the delivery catheter 412 from the two locations or points 462, 464 where the first wire 442 and second wire 444 were threaded through the graft body 426. This creates multiple “lobes” or “folds” of fabric at the proximal end 438 of the stent graft 404. As shown in FIG. 16, at least three lobes or folds 460 are formed, including at least a first fold, a second fold and a third fold when the wires 442 and 444 are pulled taut. As also shown in FIG. 16, the proximal end 452 of the delivery catheter 412 runs along the outside of the graft body 456 adjacent a first point 466 at the proximal end of the stent graft 404, thus, when the first and second wires 442, 444 are pulled taut, the second and third points 462, 464 of the stent graft are pulled towards and against the delivery catheter 412, while the delivery catheter 412 presses against a first point 466, thus drawing the first, second and third points 466, 462, 464 respectively, inwardly towards each other to pinch the proximal end 438 of the stent graft 404 into the tri-fold configuration 446.

In one example, the first wire 442 and the second wire 444 can extend longitudinally from the external handle portion of the introducer assembly 400 and then be woven through the stent graft to form the proximal attachment as described above. In one example, the first wire 442 and second wire 444 can be pulled taut by threading the proximal ends 448, 450 of the respective wires back through the center of the graft lumen and/or of the delivery catheter to extend distally back to the user so that the user can pull distally on the proximal ends 448, 450 of the respective wires to pull them taut. In other words, after the wires are woven through the graft fabric as shown in FIGS. 18-21, they may be tightened or otherwise pulled taut from the handle portion of the introducer so that the graft is pulled radially inwardly to create the tri-fold, and retained in that configuration until release is desired.

In another example, with the first wire 442 and second wire 444 releasably coupled to the graft in a manner previously described (such as in the tri-fold configuration, for example), the proximal ends 448, 450 of the respective first wire 442 and second wire 444 may extend proximally into the distal end of the nose cone dilator 410 and be retained or held in that position within the nose cone dilator 410 by various releasable attachment means including friction fit, adhesives and the like. The distal ends of the first and second wires 442, 444 may extend distally to the handle portion of the introducer and be manipulated by the user to pull the respective wires taut, thus holding the proximal end of the stent graft 404 in a constrained configuration. Release of the respective first and second wires 442, 444 to release the proximal end of the stent graft 404 may be accomplished by the user manipulating one or more release mechanisms or knobs on the handle 200 of the introducer during deployment.

FIGS. 21 and 22 illustrate how the lobes or folds 460 formed at the proximal end 438 of the graft body 426 may be folded or wrapped circumferentially around the delivery catheter 412 to reduce the diameter of the proximal tri-fold 446. More specifically, once the first wire 442 and the second wire 444 have been pulled taut and the graft body 426 has been pulled radially inwardly towards the delivery catheter 412 at the first, second and third points 466, 462, 464, respectively, the multiple lobes or folds 460 may be folded down and wrapped upon each other, in either a clock-wise or counter clock-wise direction in a fan-blade or pin-wheel-like configuration as shown in FIGS. 21 and 22. The inner surface of one lobe 460 lies down upon the outer surface of the adjacent lobe 460 thereby wrapping the proximal end 438 of the stent graft radially inwardly around and against the delivery catheter 412. In one example, the three folds include a first fold, a second fold, and a third fold, wherein the first fold at least partially overlies the second fold, the second fold at least partially overlies the third fold, and the third fold at least partially overlies the first fold. Further, in another example, the first fold and the second fold may at least partially directly overlie the delivery catheter and the third fold may at least partially indirectly overlie the delivery catheter.

In this arrangement, the sheath 402 can extend proximally over the stent graft 404 to the nose cone dilator 408, so that the introducer assembly is in a reduced-diameter low profile delivery configuration.

One of skill in the art would recognize that a single wire may be used (rather than two wires 442, 444) to weave in and out of the graft fabric to create a tri-fold configuration 446. Alternatively, one or more wires may be used to create a bi-fold or other diameter reducing fixation arrangement at the proximal end 438 of the stent graft 404 to allow the proximal end 438 to be releasably coupled to the delivery catheter, including but not limited to various wire weaving patterns and various attachment mechanisms for securing the wire to the stent graft 404 and to the delivery catheter 412.

FIGS. 23-25 illustrate various steps in one exemplary method for introducing and deploying a stent graft within a vessel using the introducer assembly 400. For example, as illustrated in FIG. 23, the introducer assembly 400 is tracked over guide wire 406 (through the lumen of the delivery catheter 412 and through the channel or lumen extending through the nose cone dilator 408) to a location within a vessel 1, with the stent graft (not shown) still covered and held in a radially inwardly contracted delivery configuration by introducer sheath 402. The sheath 402 may then be distally retracted as shown in FIG. 24, allowing the stent graft 404 to at least partially deploy from the introducer assembly 400 and become partially expanded within the vessel 1 at the site of the aneurysm 16.

As previously mentioned, the delivery catheter 412 may have a curve imparted to at least a proximal end or portion of it, and the delivery catheter thereby tends to sit adjacent to or on the greater curve of the aorta as shown in FIGS. 24 and 25. As such, the stent graft 404 will preferably open away from the delivery catheter 412 (i.e., the stent graft 404 will expand downwardly and away from the delivery catheter) as it is unsheathed during deployment, further guaranteeing proper orientation within the vessel. The delivery catheter 412 may thus be sandwiched between the outer surface of the stent graft 404 at the proximal end of the stent graft and the inner surface of the vessel wall, while facilitating alignment of the stent graft 404 within the vessel 1 as well as alignment with one or more branch vessels extending from the main vessel 1. As illustrated in FIG. 24, the proximal end 438 of stent graft 404 is still coupled to the delivery catheter 412 by wires 442, 444, which hold the proximal end 438 in the tri-fold configuration 446 after the sheath 402 has been distally retracted.

Next, as shown in FIG. 25, while the introducer assembly 400 remains within the vessel 1, and the first wire (not shown) and second wire (not shown) have been released so that the proximal end 438 of the stent graft 404 is no longer constrained radially inwardly to the delivery catheter 412 by the proximal tri-fold shown in FIG. 16. Once the stent graft 404 has been fully released from the delivery catheter 412, the user may distally retract the delivery catheter 412 (with the nose cone dilator 408 at the proximal end thereof) and withdraw it from the vessel. The guide wire 406 may remain in place within the vessel, such that it extends proximally through the lumen 422 of the stent graft 404, into the distal open end 428 of the internal branch 414, through the body 420 of the branch and out of the stent graft 404 through the proximal opening 432 at the proximal end 418 of the internal branch 414 to a location external of the graft body at the proximal end of the stent graft 404. In this way, a portion of the guide wire 406 extending proximally from the aperture 424 formed in the sidewall of the graft body is sandwiched between the outside surface 456 of the graft body 426 and the inside surface of the vessel wall. The guide wire may be manipulated by the user to extend the guide wire 406 into a branch vessel, such as the left subclavian artery 14, to cannulate this branch vessel with the guide wire 406.

At this time, if necessary and desired, a second delivery system (not shown), which may include a second delivery sheath with a bridging stent (not shown) may be extended over the guide wire 406 and tracked into the branch vessel, such as the left subclavian artery 14. The bridging stent may be deployed and the second delivery system removed from the vasculature. The deployed bridging stent (not shown) then extends from the proximal end 418 of the internal branch 414, through the aperture 424 formed in the sidewall of the graft body 426 and into the branch vessel to restore patency to the vessel.

In an alternative embodiment, as illustrated in FIG. 26, the introducer assembly 400 may be provided with a delivery catheter having a relatively smaller diameter nose cone dilator 500 at the proximal end thereof. The relatively smaller diameter nose cone dilator 500 may be sized and shaped so as to minimize the risk of the nose cone dilator 500 catching on any portion of the stent graft 404 as the delivery catheter and nose cone dilator 500 are distally retracted around the proximal end 438 of the stent graft 404 and through the lumen 422 of the stent graft 404 (and/or retracted through any aperture 424 or internal side branch 414) during removal from the vasculature. A delivery sheath 502 having an inwardly tapered proximal end may be provided to mate with the nose cone dilator 500. In one example, the relatively smaller diameter dilator 500 may be between about 8 Fr and about 16 Fr. The tapered delivery sheath 502 is tapered radially inwardly at the proximal end 504 to mate with the nose cone dilator, and is constructed of a deformable, expandable and/or elastic material, and/or a material that can be easily torn, and/or has folds in the material such that it can be contracted and expanded. As such, the tapered delivery sheath 502 can deform as it is distally retracted over the stent graft 404, therefore accommodating the larger outer diameter of the various other components of the introducer assembly 400 as the sheath slides distally by the user during deployment. FIG. 26 shows one example of a relatively smaller diameter dilator 500 and a tapered delivery sheath 502.

In an alternative example, the proximal end 438 of the stent graft 404 may comprise a slit, hole, opening or pocket (not shown) formed within the wall of the graft body 426 that is located in front of (proximal of) the branch proximal end 418 at a point approximately where the proximal attachment wires 442 and 444 extend through the graft (refer to FIG. 17). The nose cone dilator 408 and delivery catheter may then extend from the outer surface of the graft body, through the slit, hole or pocket and back into the lumen 422 at the proximal end 438 of the graft. In other words, the proximal end 452 of the delivery catheter would extend out of the proximal branch opening 432 and extend proximally on and along a portion of the outside surface at the proximal end 438 of the graft. Then, instead of continuing along the outer surface of the proximal end 438 of the stent graft 404 as shown in FIGS. 15 and 16, the nose cone dilator 410 and delivery catheter 412 would then extend back into the graft lumen 422 through this slit, opening or pocket.

While various embodiments of the invention have been described, the invention is not to be restricted except in light of the attached claims and their equivalents. Moreover, the advantages described herein are not necessarily the only advantages of the invention and it is not necessarily expected that every embodiment of the invention will achieve all of the advantages described. 

We claim:
 1. A prosthesis delivery device comprising: a delivery catheter having a proximal end, a tubular prosthesis releasably coupled to the proximal end of the delivery catheter, wherein the prosthesis has a proximal end, a distal end, a lumen extending between the proximal end and distal end, a sidewall of graft material, an inner graft surface, an outer graft surface, and a fenestration formed in the sidewall of the prosthesis, wherein the delivery catheter extends proximally through at least a portion of the prosthesis lumen and through the fenestration to a location external of the prosthesis and abutting a first point on the outer graft surface of the graft at the proximal end, a first proximal attachment mechanism releasably coupling a second point on the proximal end of the prosthesis to the delivery catheter, wherein the second point is circumferentially spaced from the first point; a second proximal attachment mechanism releasably coupling a third point on the proximal end of the prosthesis to the delivery catheter, wherein the third point is circumferentially spaced from the first point in one direction and from the second point in the opposite direction; wherein the delivery catheter further comprises at least one opening formed in a sidewall thereof and wherein the first proximal attachment mechanism extends from the at least one opening formed in the delivery catheter and is releasably coupled to the prosthesis, and wherein the second proximal attachment mechanism extends from the at least one opening formed in the delivery catheter and is releasably coupled to the prosthesis; wherein the first and second proximal attachment mechanisms draw the second and third points to the first point to form three folds of graft fabric; wherein the folds extend about the delivery catheter in a folded configuration such that at least a portion of the outer surface of the graft abuts the outer surface of the delivery catheter.
 2. The prosthesis delivery device of claim 1, wherein the three folds include a first fold, a second fold, and a third fold, wherein the first fold at least partially overlies the second fold, the second fold at least partially overlies the third fold, and the third fold at least partially overlies the first fold.
 3. The prosthesis delivery device of claim 1, wherein the three folds include a first fold, a second fold, and a third fold, wherein the first fold at least partially directly overlies the delivery catheter, the second fold at least partially indirectly overlies the delivery catheter, and the third fold at least partially indirectly overlies the delivery catheter.
 4. The prosthesis delivery device of claim 1, wherein the three folds include a first fold, a second fold, and a third fold, wherein the first fold at least partially directly overlies the delivery catheter, the second fold at least partially indirectly overlies the delivery catheter, and the third fold at least partially overlies the first fold.
 5. The prosthesis delivery device of claim 1, wherein the folded configuration is a spiral configuration.
 6. The prosthesis delivery device of claim 1 wherein the first and second attachment mechanisms each comprise a loop of wire, suture, filament or thread that extends at least partially through a lumen of the delivery catheter to a respective second or third point on the proximal end of the prosthesis.
 7. The prosthesis delivery device of claim 6 wherein the delivery catheter comprises a first opening and a second opening formed in a sidewall thereof, and wherein the first attachment mechanism extends out of the lumen of the delivery catheter through the first opening and wherein the second attachment mechanism extends out of the lumen of the delivery catheter through the second opening.
 8. The prosthesis delivery device of claim 1 wherein the second point is spaced in a first direction one-third about the circumference of the prosthesis from the fenestration, and wherein the third point is spaced in a second direction one-third about the circumference of the prosthesis from the fenestration.
 9. The prosthesis delivery device of claim 1 wherein the three folds of graft fabric are circumferentially folded upon each other.
 10. A prosthesis delivery device comprising: a delivery catheter having a proximal end, a tubular prosthesis releasably coupled to the proximal end of the delivery catheter, wherein the prosthesis has a proximal end, a distal end, a lumen extending between the proximal end and distal end, a sidewall of graft material, an inner graft surface, an outer graft surface, and a fenestration formed in the sidewall of the prosthesis, wherein the delivery catheter extends proximally through at least a portion of the prosthesis lumen and through the fenestration to a location external of the prosthesis and abutting a first point on the outer graft surface at the proximal end of the prosthesis; a first proximal attachment mechanism releasably coupling a second point on the proximal end of the prosthesis to the delivery catheter, wherein the second point is circumferentially spaced from the first point; a second proximal attachment mechanism releasably coupling a third point on the proximal end of the prosthesis to the delivery catheter, wherein the third point is circumferentially spaced from the first point in one direction and circumferentially spaced from the second point in the opposite direction; wherein the delivery catheter further comprises at least one opening formed in a sidewall thereof and wherein the first proximal attachment mechanism extends from the at least one opening formed in the delivery catheter and is releasably coupled to the prosthesis, and wherein the second proximal attachment mechanism extends from the at least one opening formed in the delivery catheter and is releasably coupled to the prosthesis; wherein the first and second proximal attachment mechanisms draw the second and third points to the first point to form first, second, and third folds of graft fabric; wherein at least a portion of the outer surface of at least one of the first, second and third folds abut the outer surface of the delivery catheter in a folded configuration.
 11. The prosthesis delivery device of claim 10, wherein the first fold at least partially overlies the second fold, the second fold at least partially overlies the third fold, and the third fold at least partially overlies the first fold.
 12. The prosthesis delivery device of claim 10, wherein the delivery catheter extends proximally from the fenestration formed in the sidewall of the prosthesis along an outer surface of the prosthesis sidewall.
 13. The prosthesis delivery device of claim 10, wherein the three folds include a first fold, a second fold, and a third fold, wherein the first fold at least partially directly overlies the delivery catheter, the second fold at least partially indirectly overlies the delivery catheter, and the third fold at least partially indirectly overlies the delivery catheter.
 14. The prosthesis delivery device of claim 10, wherein the three folds include a first fold, a second fold, and a third fold, wherein the first fold at least partially directly overlies the delivery catheter, the second fold at least partially indirectly overlies the delivery catheter, and the third fold at least partially overlies the first fold.
 15. The prosthesis delivery device of claim 10, wherein the folded configuration is a spiral configuration.
 16. The prosthesis delivery device of claim 10 wherein at least a portion of the delivery catheter has a curve imparted to it.
 17. The prosthesis delivery device of claim 16 wherein at least a portion of the prosthesis substantially conforms to the curve of the delivery catheter.
 18. The prosthesis delivery device of claim 10 wherein the delivery catheter comprises at least one opening formed in a sidewall thereof, the at least one opening located closely adjacent the proximal end of the prosthesis; and wherein the first and second attachment mechanisms extends out of a lumen of the delivery catheter through the at least one opening.
 19. The prosthesis delivery device of claim 10 wherein the delivery catheter comprises a first opening and a second opening formed in the sidewall thereof; wherein the first attachment mechanism extends from the first opening formed in the delivery catheter, through the sidewall of the prosthesis and into the prosthesis lumen, then extends out of the prosthesis lumen through the second point at the proximal end of the prosthesis, then extends back through the prosthesis sidewall into the prosthesis lumen, and wherein the second attachment mechanism extends from the second opening formed in the delivery catheter, through the sidewall of the prosthesis and into the prosthesis lumen, then extends out of the prosthesis lumen through the third point at the proximal end of the prosthesis, then extends back through the prosthesis sidewall into the prosthesis lumen.
 20. A prosthesis delivery device comprising: a delivery catheter having a proximal end, a tubular prosthesis releasably coupled to the proximal end of the delivery catheter, wherein the prosthesis has a proximal end, a distal end, and a lumen extending between the proximal end and distal end, and a fenestration formed in a sidewall of the prosthesis, wherein the delivery catheter extends proximally though at least a portion of the prosthesis lumen and through the fenestration formed in the sidewall of the prosthesis such that the delivery catheter abuts a portion of an outer surface of the prosthesis, a first attachment mechanism releasably coupling a second point at the proximal end of the prosthesis to the delivery catheter, a second attachment mechanism releasably coupling a third point at the proximal end of the prosthesis to the delivery catheter, wherein the delivery catheter further comprises at least one opening formed in a sidewall thereof and wherein the first proximal attachment mechanism extends from the at least one opening formed in the delivery catheter and is releasably coupled to the prosthesis, and wherein the second proximal attachment mechanism extends from the at least one opening formed in the delivery catheter and is releasably coupled to the prosthesis; wherein the first and second proximal attachment mechanisms have a first configuration in which the proximal end of the prosthesis is coupled to the delivery catheter and a second configuration in which the proximal end of the prosthesis is released from the delivery catheter, and wherein at least a portion of the outer surface of the prosthesis abuts an outer surface of the delivery catheter when the proximal end of the prosthesis is coupled to the delivery catheter. 